WASH-UP TOWELETTE- benzalkonium chloride swab
Jiangsu Province JianErKang Medical Dressing Co. ,Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredient

Benzalkonium Chloride, 0.13%w/w

Purpose

Antiseptic

Use

Cleans and refreshes hands and face without soap or water.

Self dries in seconds and leaves face and hands feeling soft and smooth.

Directions

Tear open packet, unfold towelette and use to clean hands and face as needed

Warnings

For external use only

Keep out reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Other information

Store at room temperature 15 o-30 oC (59 o-86 oF)

Inactive ingredients

Purified Water, Ethanol, Propylene Glycol, Fragrance, Nonoxynol-10, PEG-75 Lanolin, Sodium Bicarbonate

Image of Pouch Label

Pouch Label

WASH-UP TOWELETTE
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:34645-5048
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
NONOXYNOL-10 (UNII: K7O76887AP)
PEG-75 LANOLIN (UNII: 09179OX7TB)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Product Characteristics
Color		Score
Shape		Size
Flavor	LEMON (LEMON FLAVOR)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:34645-5048-3	1.4 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	01/01/2010	08/21/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/01/2010	08/21/2018

Labeler - Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. (530968767)

Revised: 8/2018

Document Id: 73f179c6-b448-6aa6-e053-2a91aa0a8839

Set id: b9d9ce44-12f7-4db8-a0ba-36817b8cea2b

Version: 5

Effective Time: 20180821

Jiangsu Province JianErKang Medical Dressing Co. ,Ltd.